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1. WO2020227249 - DISPOSITIF CINCH ET PROCÉDÉ DE DÉPLOIEMENT D'UNE VALVULE CARDIAQUE PROTHÉTIQUE À POSE LATÉRALE DANS UN ANNEAU NATIF

Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

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Claims

CLAIM 1 . An orthogonally delivered transcatheter prosthetic heart valve having an integrated cinching apparatus, comprising:

a self-expanding annular support frame, said annular support frame having a central channel and an outer perimeter wall circumscribing a central vertical axis in an expanded configuration, an atrial sealing collar is disposed around at least a portion of a top edge of the outer perimeter wall, said annular support frame having a distal side and a proximal side,

an integrated cinching apparatus having an elongated tether or strap releasably attached at a distal end to the annular support frame, the tether or strap actuable from a control handle of a steerable catheter to cinch or reduce the radial size of the proximal side of the annular support frame;

a flow control component mounted within the annular support frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve,

a subannular distal anchoring tab or tension arm is attached to a distal portion of the perimeter wall and extending away from the perimeter wall,

a subannular proximal anchoring tab or tension arm attached to a proximal portion of the perimeter wall and extending away from the perimeter wall,

wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration is oriented along a horizontal axis at an intersecting angle of between 45-135 degrees to the central vertical axis, and expandable to an expanded configuration having a horizontal axis at an intersecting angle of between 45-135 degrees to the central vertical axis,

wherein the horizontal axis of the compressed configuration of the valve is substantially parallel to a lengthwise cylindrical axis of the delivery catheter.

CLAIM 2. The valve of claim 1 , wherein the integrated cinching apparatus has two or more tethers.

CLAIM 3. The valve of claim 1 , wherein the integrated cinching apparatus comprises a single-pull tether mechanism, a double tether pulling system, a multiple tether twisting mechanism, or a belt cinching mechanism.

CLAIM 4. The valve of claim 2, wherein the tether is braided polyethylene, treated pericardial tissue, ePTFE, or Nitinol.

CLAIM 5. The valve of claim 1 , wherein the tether or strap has a tooth-portion and the releasing element has tooth-engaging releasable pawl element.

CLAIM 6. The valve of claim 1 , wherein the first tether or strap is attached to a top portion of a septal side of the perimeter wall, and the second tether or strap is attached to a bottom portion of the septal side of the perimeter wall.

CLAIM 7. The valve of claim 1 , wherein the tether or strap is releasably attached to the subannular proximal anchoring tab, and the proximal anchoring tab is configured to move from a folded up position against the perimeter wall to an expanded position folding away from the perimeter wall, wherein the proximal anchoring tab has a tab anchoring element, and the tether or strap has a tab releasing element that cooperates with the tab anchoring element to move the proximal anchoring tab from the folded up position to the expanded position.

CLAIM 8. The valve of claim 1 , wherein the annular support frame is covered with a biocompatible material.

CLAIM 9. The valve of claim 1 , wherein the annular support frame is comprised of a plurality of compressible wire cells having an orientation and cell geometry substantially orthogonal to the central vertical axis to minimize wire cell strain when the annular support frame is configured in a vertical compressed configuration, a rolled compressed configuration, or a folded compressed configuration.

CLAIM 10. The valve of claim 1 , wherein the annular support frame has a lower body portion and an upper collar portion, wherein the lower body portion in an expanded configuration forms a shape selected from a funnel, cylinder, flat cone, or circular hyperboloid.

CLAIM 1 1 . The valve of claim 1 , wherein said annular support frame is comprised of a braided, wire, or laser-cut wire frame, and said annular support frame is covered with a biocompatible material.

CLAIM 12. The valve of claim 1 , wherein the annular support frame has a side profile of a flat cone shape having a diameter R of 40-80mm, a diameter r of 20-60mm, and a height of 5-60mm.

CLAIM 13. The valve of claim 1 , wherein the annular support frame has an inner surface and an outer surface, said inner surface and said outer surface covered with a biocompatible material selected from the following consisting of: the inner surface covered with pericardial tissue, the outer surface covered with a woven synthetic polyester material, and both the inner surface covered with pericardial tissue and the outer surface covered with a woven synthetic polyester material.

CLAIM 14. The valve of claim 1 , wherein the annular support frame has a side profile of an hourglass shape having a top diameter R1 of 40-80mm, a bottom diameter R2 of 50-70mm, an internal diameter r of 20-60mm, and a height of 5-60mm.

CLAIM 15. The valve of claim 1 , wherein the valve in an expanded configuration has a central vertical axis that is substantially parallel to the first direction.

CLAIM 16. The valve of claim 1 , wherein the flow control component has an internal diameter of 20-40mm, and a plurality of leaflets of pericardial material joined to form a rounded cylinder at an inflow end and having a flat closable aperture at an outflow end.

CLAIM 17. The valve of claim 1 , wherein the flow control component is supported with one or more longitudinal supports integrated into or mounted upon the flow control component, the one or more longitudinal supports selected from rigid or semi-rigid posts, rigid or semi-rigid ribs, rigid or semi-rigid battens, rigid or semi-rigid panels, and combinations thereof.

CLAIM 18. The valve of claim 1 , wherein the subannular distal anchoring tab is comprised of wire loop, a wire frame, a laser cut frame, an integrated frame section, or a stent, and the distal anchoring tab extends from about 20-40mm away from the distal side of the annular support frame.

CLAIM 19. The valve of claim 1 , wherein the proximal anchoring tab is comprised of wire loop, a wire frame, a laser cut frame, an integrated frame section, or a stent, and the proximal anchoring tab extends from about 10-20mm away from the proximal side of the annular support frame.

CLAIM 20. The valve of claim 1 , further comprising an upper distal anchoring tab attached to a distal upper edge of the annular support frame, the upper distal anchoring tab comprised of wire loop, a wire frame, a laser cut frame, an integrated frame section, or a stent, and extends from about 10-20mm away from the annular support frame.

CLAIM 21. The valve of claim 1 , comprising at least one tissue anchor connected to the annular support frame for engaging native tissue.

CLAIM 22. The valve of claim 1 , wherein the outer perimeter wall comprises a front wall portion that is a first flat panel and a back wall portion that is a second flat panel, and wherein a proximal fold area and a distal fold area each comprise a sewn seam, a fabric panel, a rigid hinge, or a flexible fabric span without any wire cells.

CLAIM 23. The valve of claim 1 , wherein the annular support frame is comprised of compressible wire cells selected from the group consisting of braided-wire cells, laser-cut wire cells, photolithography produced wire cells, 3D printed wire cells, wire cells formed from intermittently connected single strand wires in a wave shape, a zig-zag shape, or spiral shape, and combinations thereof.

CLAIM 24. A process for manufacturing an orthogonally delivered transcatheter prosthetic heart valve frame, comprising:

using additive or subtractive metal or metal-alloy manufacturing to produce

a self-expanding annular support frame, said annular support frame having a central channel and an outer perimeter wall circumscribing a central vertical axis in an expanded configuration, an atrial sealing collar is disposed around at least a portion of a top edge of the outer perimeter wall, said annular support frame having a distal side and a proximal side,

an integrated cinching apparatus comprising an elongated tether or strap releasably attached at a distal end to the annular support frame, the tether or strap having a releasing element at the distal end that is actuated from a control handle at a proximal end of the tether or strap, the releasing element configured to cooperate with an anchoring frame element on the annular support frame, the tether or strap slidably housed within a lumen of at least one slidable guide element mounted on the perimeter wall at a location proximal to the distal end,

a flow control component mounted within the annular support frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve,

an integrated subannular anchor system attached to the annular support frame, the anchor system comprising an elongated tether or strap attached at a distal end to a rigid loop, and a slidable locking element slidably attached to the elongated tether or strap,

a distal anchoring tab mounted on the distal side of the annular support frame,

a proximal anchoring tab mounted on the proximal side of the annular support frame,

wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration is oriented along a horizontal axis at an intersecting angle of between 45-135 degrees to the central vertical axis, and expandable to an expanded configuration having a horizontal axis at an intersecting angle of between 45-135 degrees to the central vertical axis,

wherein the horizontal axis of the compressed configuration of the valve is substantially parallel to a lengthwise cylindrical axis of the delivery catheter,

wherein the valve has a height of about 5-60mm and a diameter of about 25-80mm,

wherein the additive metal or metal-alloy manufacturing is 3D printing or direct metal laser sintering (powder melt), and

wherein the subtractive metal or metal-alloy manufacturing is photolithography, laser sintering/cutting, CNC machining, electrical discharge machining.

CLAIM 25. The process of claim 24, further comprising the steps of:

(ii) mounting a flow control component within the valve frame, said flow control component configured to permit blood flow along the central vertical axis through an inflow end of the flow control component and block blood flow through an outflow end of the valve,

covering an outer surface of the valve frame with a pericardium material or similar biocompatible material.

CLAIM 26. A method for compressing an implantable prosthetic heart valve for length-wise orthogonal release of the valve from a delivery catheter, comprising:

flattening, rolling or folding the implantable prosthetic heart valve into a compressed configuration wherein the long-axis of the compressed configuration of the valve is substantially parallel to a length-wise cylindrical axis of the delivery catheter,

wherein the implantable prosthetic heart valve comprises an annular support frame having a flow control component mounted within the annular support frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve,

an integrated subannular anchor system attached to the annular support frame,

a distal anchoring tab mounted on a distal side of the annular support frame,

a proximal anchoring tab mounted on a proximal side of the annular support frame.

CLAIM 27. The method of claim 20, wherein the implantable prosthetic heart valve is rolled or folded into a compressed configuration using a step selected from the group consisting of:

unilaterally rolling into a compressed configuration from one side of the annular support frame;

bilaterally rolling into a compressed configuration from two opposing sides of the annular support frame; flattening the annular support frame into two parallel panels that are substantially parallel to the long-axis, and then rolling the flattened annular support frame into a compressed configuration; and

flattening the annular support frame along a vertical axis to reduce a vertical dimension of the valve from top to bottom.

CLAIM 28. A method for orthogonal delivery of implantable prosthetic heart valve to a desired location in the body, the method comprising the steps:

advancing a delivery catheter to the desired location in the body and delivering an expandable prosthetic heart valve to the desired location in the body by releasing the valve from the delivery catheter, wherein the valve comprises a self-expanding annular support frame, said annular support frame having a central channel and an outer perimeter wall circumscribing a central vertical axis in an expanded configuration, an atrial sealing collar is disposed around at least a portion of a top edge of the outer perimeter wall, said annular support frame having a distal side and a proximal side,

an integrated cinching apparatus;

a flow control component mounted within the annular support frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve,

a distal anchoring tab mounted on a distal side of the annular support frame, and

a proximal anchoring tab mounted on a proximal side of the annular support frame,

wherein said valve is cinchable to a cinched configuration having an elliptical circumference from 5-30% reduced from an expanded configuration, or having a cinched configuration where a long-axis of the top edge is reduced 5-30% in diameter,

wherein the valve is compressible to a compressed configuration having a height of 5-10mm and a width of 5-10mm for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction,

wherein the long-axis of the compressed configuration of the valve is substantially parallel to a length-wise cylindrical axis of the delivery catheter.

CLAIM 29. The method of claim 28, wherein releasing the valve from the delivery catheter is selected from the steps consisting of: (i) pulling the valve out of the delivery catheter using a rigid elongated pushing rod/draw wire that is releasably connected to the distal side of the valve, wherein advancing the pushing rod away from the delivery catheter pulls the compressed valve out of the delivery catheter, or (ii) pushing the valve out of the delivery catheter using a rigid elongated pushing rod that is releasably connected to the proximal side of the valve, wherein advancing the pushing rod out of from the delivery catheter pushes the compressed valve out of the delivery catheter.

CLAIM 30. The method of claim 28, comprising the additional step of anchoring one or more tissue anchors attached to the valve into native tissue.

CLAIM 31. The method of claim 28, comprising the additional step of positioning the distal anchoring tab of the heart valve prosthesis into the right ventricular outflow tract of the right ventricle.

CLAIM 32. The method of claim 28, comprising the additional steps of positioning the distal anchoring tab of the heart valve prosthesis into the right ventricular outflow tract of the right ventricle, and positioning an upper distal anchoring tab into a supra-annular position, and the upper distal anchoring tab providing a supra-annular downward force in the direction of the ventricle and distal anchoring tab providing a sub-annular upward force in the direction of the atrium.

CLAIM 33. The method of claim 28, comprising the the additional step of rotating the heart valve prosthesis using a steerable catheter along an axis parallel to the plane of the valve annulus.

CLAIM 34. A method for orthogonal delivery of implantable prosthetic heart valve in the body, the method comprising the steps:

advancing a distal end of a guide wire to a distal location, wherein the distal location is a pulmonary artery or a left ventricle of a heart, wherein the guide wire starts outside of a patient using femoral vein access or brachiocephalic vein access, and extends through an inferior vena cava or a superior vena cava to a right atrium, and extends from the right atrium through the tricuspid valve to the pulmonary artery or extends from the right atrium across the atrial septum in a transseptal access through the mitral valve and into a left ventricle;

advancing a delivery catheter over the guide wire to a target location, where the target location is a right atrium of the tricuspid valve or a left atrium of the mitral valve;

advancing and delivering an orthogonally compressed self-expandable prosthetic heart valve to the target location in the body,

wherein a compressed configuration of the valve has a long-axis substantially parallel to a length-wise cylindrical axis of the delivery catheter,

wherein the expanded configuration of the valve has a height of about 5-60mm and a diameter of about 25-80mm,

wherein the valve comprises an annular support frame having a flow control component mounted within the annular support frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve,

an integrated subannular anchor system attached to the annular support frame,

a distal anchoring tab is mounted on a distal side of the annular support frame, wherein the guide wire is threaded through a threading aperture on or within the distal anchoring tab,

at least one proximal anchoring tab is mounted on a proximal side of the annular support frame, and a valve advancing tool comprising an elongated sheath wherein the guide wire is within a lumen of the sheath, wherein the outer diameter of the sheath is larger than the inner diameter of the threading aperture on the distal anchoring tab, wherein when the sheath is advanced over the guide wire in a distal direction, and a distal end of the sheath contacts a proximal surface of the threading aperture, the valve is advanced distally through the delivery catheter by the d istal ly-d i reefed pulling force that the sheath imparts to the distal anchoring tab;

(iv) partially releasing the valve from the delivery catheter by advancing the sheath over the guide wire, and positioning the distal anchoring tab at a desired anchoring area of the target location,

wherein the desired anchoring area is selected from a right ventricular outflow tract (RVOT) of a right ventricle, and a sub-annular area below an A1 -P1 antero-lateral commissure of a mitral valve, wherein positioning the distal anchoring tab holds the valve at a raised angle of at least 30 degrees to a localized annular plane relative to the horizontal axis of the valve and the delivery catheter,

wherein partially releasing the valve permits blood to flow partially around the prosthetic valve and through the native leaflets, and partially through the flow control component of the prosthetic valve to provide a gradual blood flow transition from flow through native leaflets to complete flow through the prosthetic valve;

(v) completing release of the entire valve from the delivery catheter by advancing the sheath over the guide wire, seating the valve in the native annulus by applying a downward force in the direction of the ventricle; and

(vi) seating the at least one proximal anchoring tab at a second desired anchoring area.

CLAIM 35. The method of claim 21 , comprising the additional step of anchoring one or more tissue anchors attached to the valve into native tissue.

CLAIM 36. A method for improving hemodynamic flow during implantation of a transcatheter prosthetic heart valve, comprising:

advancing a delivery catheter to the desired location in the body and delivering the valve of claim 1 to the desired location in the body;

partially releasing the valve from the delivery catheter to establish blood flow around the partially released valve and establish blood flow through the flow control component;

completely releasing the valve from the delivery catheter while maintaining attachment to the valve with a positioning catheter or wire to transition to increased blood flow through the flow control component and decreasing blood flow around the valve; and

deploying the valve into a final mounted position to transition to complete blood flow through the flow control component and minimal or no blood flow around the valve, and disconnecting and withdrawing the positioning catheter or wire from the valve.

CLAIM 37. The method of Claim 36, wherein the distal anchoring tab is an RVOT tab positioned in the RVOT during the transition from partial release of the valve to complete release of the valve.